TOF-GUARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-08 for TOF-GUARD manufactured by Organon Teknika Corp..

Event Text Entries

[19674] Skin under proximal electrode of peripheral left nerve stimulator left volar surface upper extremity at the wrist had minor injury secondary to the device. Several small petechiae noted. He had undergone ulnar nerve stimulation intermittently for 4 days monitoring degree of neuromuscular blockade by study drug.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1008299
MDR Report Key29973
Date Received1996-02-08
Date of Report1996-02-01
Date of Event1996-01-08
Date Added to Maude1996-02-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTOF-GUARD
Generic NamePERIPHERAL NERVE STIMULATOR
Product CodeGZI
Date Received1996-02-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key31066
ManufacturerORGANON TEKNIKA CORP.
Manufacturer AddressTURNHOUT BE


Patients

Patient NumberTreatmentOutcomeDate
10 1996-02-08

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